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New drug combo aims to shrink Hard-to-Treat melanoma

NCT ID NCT07449754

Disease control Sponsor: Hanmi Pharmaceutical Company Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing two oral drugs, belvarafenib and cobimetinib, in about 45 people with advanced or spreading melanoma that has a specific genetic change called an NRAS mutation. The goal is to see if the combination can shrink tumors and keep the disease under control. Participants take the drugs daily for 28-day cycles, and the study measures how many respond and how long the benefit lasts.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
belvarafenib and cobimetinib (oral targeted drugs)
What this could lead to
If successful, this combination could offer a new treatment option for people with NRAS-mutant melanoma that has spread or cannot be removed by surgery.
What could go wrong
This is a small, early-phase study with no comparison group. The drugs may not work well enough or could cause significant side effects. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Have histologically, cytologically confirmed locally advanced or metastatic melanoma for which no adequate standard of care exists, or for which standard of care has failed or is not tolerated. * Have NRAS mutation. * Have at least one measurable lesion at baseline per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Age of 19 years or older * Adequate renal, hematologic and liver function. Key Exclusion Criteria: * Have a history of prior treatment with RAF, MEK, or ERK inhibitor. * Have past history or ongoing retinal pathology that is considered a risk factor for retinopathy or RVO. * Have past history or ongoing cardiac function-related disorders. * Had hemorrhage or bleeding corresponding to CTCAE Grade ≥3 within 4 weeks prior to the first dose of study drug treatment (Cycle 1 Day 1).

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced or metastatic melanoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Chonnam National University Hwasun Hospital

    NOT_YET_RECRUITING

    Hwasun, Jeollanam-do, 58128, South Korea

  • Chungnam National University Hospital

    NOT_YET_RECRUITING

    Daejeon, 35015, South Korea

  • Dong-A University Medical Center

    RECRUITING

    Busan, 49201, South Korea

  • Korea University Guro Hospital

    NOT_YET_RECRUITING

    Seoul, 08308, South Korea

  • Kyungpook National University Chilgok Hospital

    NOT_YET_RECRUITING

    Daegu, 41404, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Bundang Hospital

    NOT_YET_RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Seoul National University Hospital

    NOT_YET_RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

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